Systems and methods to improve instrument guidance within an intravenous catheter assembly

ABSTRACT

A catheter assembly and/or an introducer may include one or more features configured to guide a probe and/or a catheter distally through a septum. The catheter assembly may include a catheter adapter and the septum. The catheter adapter may include a distal end, a proximal end, and a lumen extending therebetween. In some embodiments, the septum may be disposed within the lumen. The septum may include a proximal surface that is tapered inwardly in a distal direction such that the proximal surface of the septum is configured to guide the probe and/or the catheter distally through the septum. The catheter assembly may be configured to receive an introducer, which may include an introducer element. A proximal end of the introducer element may include another proximal surface that is tapered inwardly in the distal direction such that the other proximal surface is configured to guide the probe or the catheter distally through the septum.

RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.16/037,274, filed Jul. 17, 2018, entitled SYSTEMS AND METHODS TO IMPROVEINSTRUMENT GUIDANCE WITHIN AN INTRAVENOUS CATHETER ASSEMBLY, whichclaims the benefit of U.S. Provisional Patent Application No.62/534,557, filed Jul. 19, 2017, entitled SYSTEMS AND METHODS TO IMPROVEINSTRUMENT GUIDANCE WITHIN AN INTRAVENOUS CATHETER ASSEMBLY, which areincorporated herein in their entirety.

BACKGROUND

Catheters are commonly used for a variety of infusion therapies. Forexample, catheters may be used for infusing fluids, such as normalsaline solution, various medicaments, and total parenteral nutrition,into a patient. Catheters may also be used for withdrawing blood fromthe patient.

A common type of catheter is an over-the-needle peripheral intravenous(“IV”) catheter. As its name implies, the over-the-needle catheter maybe mounted over an introducer needle having a sharp distal tip. Thecatheter and the introducer needle may be assembled so that the distaltip of the introducer needle extends beyond the distal tip of thecatheter with the bevel of the needle facing up away from skin of thepatient. The catheter and introducer needle are generally inserted at ashallow angle through the skin into vasculature of the patient.

In order to verify proper placement of the introducer needle and/or thecatheter in the blood vessel, a clinician generally confirms that thereis “flashback” of blood in a flashback chamber of the catheter assembly.Once placement of the needle has been confirmed, the clinician maytemporarily occlude flow in the vasculature and remove the needle,leaving the catheter in place for future blood withdrawal or fluidinfusion.

Blood withdrawal using a peripheral IV catheter may be difficult forseveral reasons, particularly when an indwelling time of the catheter ismore than one day. For example, when the catheter is left inserted inthe patient for a prolonged period of time, the catheter may be moresusceptible to narrowing, collapse, kinking, blockage by debris (e.g.,fibrin or platelet clots), and adhering of a tip of the catheter to thevasculature. Due to this, catheters may often be used for acquiring ablood sample at a time of catheter placement but are much lessfrequently used for acquiring a blood sample during the catheter dwellperiod. Therefore, when a blood sample is required, an additional needlestick may be needed to provide vein access for blood collection, whichmay be painful for the patient and result in higher material costs.Accordingly, there is a need for catheter systems and methods thatfacilitate placement of blood sample instruments, such as, for example,catheters, and probe instruments in the vasculature of the patientwithout additional needle sticks.

BRIEF SUMMARY OF THE INVENTION

The present application relates generally to instrument guidance withina catheter system, which may include a peripheral IV catheter system. Insome embodiments, the catheter system may include a catheter assembly.In some embodiments, the catheter assembly may include one or more ofthe following: a catheter, a catheter adapter, a septum housing, and aseptum.

In some embodiments, the catheter adapter may include a distal end, aproximal end, and a lumen extending therebetween. In some embodiments,the septum may be disposed within the lumen of the catheter adapter. Insome embodiments, the septum may be at least partially disposed withinthe septum housing and configured to at least substantially seal thelumen of the catheter adapter. In some embodiments, the septum housingmay prevent dislodgement or destabilization of the septum, therebypreventing leakage of fluid from the lumen of the catheter adapter.

In some embodiments, the catheter assembly may be part of a closed IVcatheter system or a catheter system with an integrated extension tube,such as, for example, the Becton Dickinson NEXIVA™ Closed IV CatheterSystem, the Becton Dickinson NEXIVA™ DIFFUSICS™ Closed IV CatheterSystem, or the Becton Dickinson PEGASUS™ Safety Closed IV CatheterSystem. In these and other embodiments, a proximal end of the catheteradapter may include a first port and a second port. In these and otherembodiments, the lumen of the catheter adapter may include a first lumenand/or a second lumen. In some embodiments, the first port may form thefirst lumen and/or the second port may form the second lumen. In someembodiments, the first and second lumens may join at a common lumen. Insome embodiments, the first lumen may be generally aligned with thecommon lumen and/or the second port may include a side port. In someembodiments, the septum and/or the septum housing may be disposed in thefirst lumen.

In the closed IV catheter system, an introducer needle may be withdrawnthrough the catheter adapter after insertion of the catheter intovasculature of a patient. In the closed IV catheter system, when theintroducer needle is withdrawn through the catheter adapter, the firstlumen, which may correspond to a “needle channel,” may be closed off bythe septum from an external environment surrounding the catheteradapter. Thus, the septum may at least substantially seal the first portand prevent fluid from exiting the catheter adapter through the firstport. In some embodiments, a fluid pathway of the catheter assemblyduring fluid infusion and/or blood withdrawal may extend through thesecond port and not the first port.

In some embodiments, the second lumen of the catheter adapter may beconnectable to blood withdrawal or infusion means via an extension tubethat may extend from the second port of the catheter adapter. In someembodiments, the septum and/or the septum housing may be disposedproximal to the second port of the catheter adapter. In someembodiments, the catheter assembly may be part of another type ofcatheter system, such as, for example, a non-integrated catheter systemor a catheter system without the integrated extension tube.

In some embodiments, the instrument may include another catheter or aprobe. In some embodiments, the instrument may include a variablediameter along a length of the instrument. In some embodiments, theinstrument may be guided by one or more features of the catheter system,such as, for example, one or more tapered surfaces, to allow theinstrument to access a fluid pathway of the catheter assembly and/or thevasculature of the patient. In some embodiments, one or more features ofthe catheter system may guide the instrument through the septum toaccess the fluid pathway. In some embodiments, by accessing the fluidpathway and/or the vasculature through the septum, insertion of theinstrument through a long and tortuous path of an integrated extensionset may be avoided.

In some embodiments, the septum may include a proximal surface that istapered inwardly in a distal direction such that the proximal surface isconfigured to guide an instrument distally through the septum. In someembodiments, the septum may include a cavity. In some embodiments, adistal end of the cavity may include an annular protrusion, which mayform the proximal surface of the septum. In some embodiments, the septummay include a slit disposed at or near a center of or within the annularprotrusion. In some embodiments, the proximal surface of the septum mayinclude an inner surface of the septum or a surface of the septumdisposed towards the slit of the septum.

In some embodiments, the septum housing may include a proximal surfacethat is tapered inwardly in the distal direction such that the proximalsurface of the septum housing is configured to guide the instrumentdistally through the septum. In some embodiments, the septum housing mayinclude a distal end and a proximal end. In some embodiments, the septummay be disposed at least partially within the distal end of the septumhousing. In some embodiments, the proximal end of the septum housing mayinclude the proximal surface of the septum housing. In some embodiments,the septum housing may include a canister.

In some embodiments, the catheter system may include an extension orintroducer, which may be configured to introduce the instrument into thecatheter assembly. In some embodiments, the introducer may include anintroducer element, which may be coupled with the proximal end of thecatheter adapter. In some embodiments, a proximal end of the introducerelement may include an opening being at least partially formed by aproximal and/or an inner surface. In some embodiments, the inner surfacemay be tapered inwardly in the distal direction such that the innersurface is configured to guide the instrument distally through theintroducer element and into the proximal end of the catheter adapter.

In some embodiments, the proximal end of the introducer element mayinclude a coupling mechanism. In some embodiments, a distal end of theintroducer element may include a tube or tubular element. In someembodiments, in response to the introducer being coupled to the catheteradapter via the coupling mechanism, the tube may penetrate the septumand/or extend proximate a proximal face of septum, which may help guidethe instrument within the catheter assembly. In some embodiments, adistal end of the tube may be blunt, which may prevent harm to theseptum.

In some embodiments, the introducer may include a cover disposed overtop or at least partially covering the tube. In some embodiments, thecover may contact the proximal face of the septum. In some embodiments,the cover may be elastomeric. In some embodiments, the cover may includea slit, which may facilitate penetration of the cover by the instrument.In some embodiments, the slit of the cover may be aligned with the slitof the septum. In some embodiments, the cover may include one or moreantimicrobial agents. In some embodiments, the cover may be configuredto seal the introducer from any fluid leakage through the septum whenthe septum is closed.

In some embodiments, the introducer may include a sheath or sleeve,which may be coupled to the introducer element. In some embodiments, thesleeve may surround the instrument, which may protect the instrumentfrom the external environment surrounding the introducer. In someembodiments, the instrument may be at least partially disposed withinthe sleeve. In some embodiments, the instrument may be advanced to aposition beyond a distal end of the sleeve when the sleeve is compressedor collapsed in the distal direction. In some embodiments, theintroducer may include a grip, which may be coupled to a proximal end ofthe sleeve. In some embodiments, a clinician may move the grip distallyto compress or collapse the sleeve in the distal direction and advancethe instrument to the position beyond the distal end of the sleeve. Insome embodiments, the coupling mechanism may be coupled to a particularport of the catheter adapter. In some embodiments, the fluid may beprevented by the septum from exiting the catheter adapter via theparticular port. In some embodiments, the sleeve may be at leastpartially disposed in a housing, as will be described in further detail.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

In order that the manner in which the above-recited and other featuresand advantages of the invention are obtained will be readily understood,a more particular description of the invention briefly described abovewill be rendered by reference to specific embodiments thereof that areillustrated in the appended drawings. These drawings depict only typicalembodiments of the invention and are not therefore to be considered tolimit the scope of the invention.

FIG. 1A is a cross-sectional top view of an example catheter assembly,according to some embodiments;

FIG. 1B is a partial exploded view of the catheter assembly of FIG. 1A,according to some embodiments;

FIG. 1C is an upper perspective view of an example needle hub configuredto be coupled with the catheter assembly of FIG. 1A, according to someembodiments;

FIG. 2A is a cross-sectional view of an example septum that includes aguidance feature, according to some embodiments;

FIG. 2B is a cross-sectional view of another example septum thatincludes the guidance feature of FIG. 2A and another guidance feature,according to some embodiments;

FIG. 2C is a cross-sectional view of a septum housing having anotherexample guidance feature, according to some embodiments, according tosome embodiments;

FIG. 2D is an upper perspective view of the septum housing of FIG. 2C,according to some embodiments;

FIG. 3A is a cross-sectional view of an example introducer coupled toanother example catheter assembly, illustrating the introducer in afirst position, according to some embodiments;

FIG. 3B is a cross-sectional view of the introducer of FIG. 3A,illustrating the introducer in a second position, according to someembodiments;

FIG. 3C is a cross-sectional view of another example introducer,illustrating the introducer in the second position, according to someembodiments;

FIG. 3D is a cross-sectional view of an example cover disposed on anexample introducer element, according to some embodiments;

FIG. 4A is a cross-sectional view of another example introducer,according to some embodiments;

FIG. 4B is a cross-sectional view of the introducer of FIG. 4A,according to some embodiments; and

FIG. 5 is a cross-sectional view of the introducer of FIG. 4A, accordingto some embodiments.

DETAILED DESCRIPTION OF THE INVENTION

The presently preferred embodiments of the present invention can beunderstood by reference to the drawings, wherein like reference numbersindicate identical or functionally similar elements. It will be readilyunderstood that the components of the present invention, as generallydescribed and illustrated in the figures herein, could be arranged anddesigned in a wide variety of different configurations. Thus, thefollowing more detailed description, as represented in the figures, isnot intended to limit the scope of the invention as claimed, but ismerely representative of presently preferred embodiments of theinvention. Moreover, the Figures may show simplified or partial views,and the dimensions of elements in the Figures may be exaggerated orotherwise not in proportion for clarity.

As used in the present disclosure, the terms “proximal” and “distal” mayrefer to the direction closer to and away from, respectively, aclinician who would place the catheter system into contact with apatient. Thus, for example, the end of the catheter system firsttouching the body of the patient would be the distal end, while theopposite end of the catheter system (e.g., the end of the device beingmanipulated by the clinician) would be the proximal end of the cathetersystem.

The present application relates generally to instrument guidance withina catheter system, which may include a peripheral IV catheter system.Referring now to FIGS. 1A-1C, in some embodiments, the catheter systemmay include a catheter assembly 10. In some embodiments, the catheterassembly may include one or more of the following: a catheter 12, acatheter adapter 14, a septum housing 16, and a septum 18.

In some embodiments, the catheter adapter 14 may include a distal end, aproximal end, and a lumen 20 extending therebetween. In someembodiments, the septum 18 may be disposed within the lumen 20 of thecatheter adapter 14. In some embodiments, the septum 18 may be at leastpartially disposed within the septum housing 16. In some embodiments,the septum housing 16 may prevent dislodgement or destabilization of theseptum 18, thereby preventing leakage of fluid from the catheter adapter14. In some embodiments, the septum 18 and the septum housing 16 mayinclude or correspond to any of the septa 18 and septum housings 16,respectively, illustrated in any of the other Figures.

In some embodiments, the catheter assembly 10 may be part of a closed IVcatheter system or catheter system with an integrated extension tube,such as, for example, the BD NEXIVA™ Closed IV Catheter System, the BDNEXIVA™ DIFFUSICS™ Closed IV Catheter System, or the Becton DickinsonPEGASUS™ Safety Closed IV Catheter System. In these and otherembodiments, a proximal end of the catheter adapter 14 may include afirst port 22 and a second port 24. In these and other embodiments, thelumen 20 of the catheter adapter 14 may include a first lumen 20 aand/or a second lumen 20 b. In some embodiments, the first port 22 mayform the first lumen 20 a and/or the second port 24 may form the secondlumen 20 b. In some embodiments, the first and second lumens 20 a,20 bmay join at a common lumen 20 c. In some embodiments, the first lumen 20a may be generally aligned with the common lumen 20 c and/or the secondport 24 may include a side port. In some embodiments, the septum 18and/or the septum housing 16 may be disposed in the first lumen 20 a. Insome embodiments, the septum 18 may be configured to at leastsubstantially seal the first lumen 20 a of the catheter adapter 14.

In the integrated or closed IV catheter system, an introducer needle 26may be withdrawn through the catheter adapter 14 after insertion of thecatheter 12 into the vasculature of a patient. In the integrated orclosed IV catheter system, when the introducer needle 26 is withdrawnthrough the catheter adapter 14, the first lumen 20 a, which maycorrespond to a “needle channel,” may be closed off by the septum 18from an external environment surrounding the catheter adapter 14. Thus,the septum 18 may prevent fluid from exiting the catheter adapter 14through the first port 20 a. In some embodiments, a fluid pathway of thecatheter assembly 10 during fluid infusion and/or blood withdrawal mayextend through the second port 20 b and may not extend through the firstport 20 a and the septum 18.

In some embodiments, the second lumen 20 b of the catheter adapter 14may be connectable to blood withdrawal or infusion means via anextension tube 28 that may extend from the second port 20 b of thecatheter adapter 14. In some embodiments, the septum 18 and/or theseptum housing 16 may be disposed proximal to the second port 20 b ofthe catheter adapter 14.

It is understood that the catheter assembly 10 may include any number ofports. For example, the catheter assembly 10 may include a single portin which the septum 18 and/or the septum housing 16 may be disposed. Insome embodiments, the catheter assembly 10 may include the first port 20a, the second port 20 b, and one or more additional ports. In someembodiments, fluid may be prevented by the septum 18 from exiting thecatheter adapter 14 via a particular port in which the septum 18 isdisposed. In some embodiments, the catheter assembly 10 may be part ofanother type of catheter system, such as, for example, a non-integratedcatheter system. In some embodiments, the extension tubing 28 and/orsecond port 20 b may be absent. In these and other embodiments, thefluid pathway of the catheter adapter 14 may extend through the septum18.

In some embodiments, the septum 18 may include a slit 40. In furtherdetail, in some embodiments the septum 18, may be pre-slit prior toinsertion of the introducer needle 26 through the septum 18 or the slit40 may be formed when the introducer needle 26 is inserted through theseptum 18. In some embodiments, the introducer needle 26 may be coupledto a needle hub 27, which may include a needle safety mechanism.

Referring now to FIGS. 2A-2C, in some embodiments, an instrument mayinclude another catheter and/or a probe 30. An example of the probe 30is illustrated in FIGS. 2A-2C. However, the probe 30 may be replacedwith the other catheter, an example of which is illustrated in FIGS.3A-3B. In some embodiments, the instrument may function as both theprobe 30 and the other catheter. In some embodiments, the instrument maybe useful for one or more of the following: diagnostics, blood sampling,monitoring, and one or more other purposes.

In some embodiments, the instrument may be guided by one or morefeatures of the catheter system, such as, for example, one or moretapered surfaces, to allow the instrument to access the fluid pathway ofthe catheter assembly 10 and/or the vasculature of the patient. In someembodiments, the one or more features of the catheter system may includelead-in features and/or may guide the instrument through the septum 18to access the fluid pathway of the catheter assembly 10. In someembodiments, by accessing the fluid pathway and/or the vasculaturethrough the septum 18, insertion of the instrument through a long andtortuous path of an integrated extension set may be avoided.

In some embodiments, the other catheter may include a replacementcatheter, which may be needleless. In some embodiments, the probe 30 mayinclude one or more openings 31 and/or one or more sensors 32. In someembodiments, the openings 31 and/or the sensors 32 may be disposedtowards a distal tip of the probe 30. In some embodiments, the openings31 may serve as fluid inlets and/or outlets. In some embodiments, thesensors 32 may measure one or more parameters and/or detect one or moreelements related to, for example, diagnostic information, bloodchemistry, pressure, flow rate, drug identification, microbes, placementof an implantable stent, in-vein catheter tip stabilization feature, orother device, etc. In some embodiments, the one or more features mayfacilitate placement of a portion of the probe 30 that includes thesensors 32 within the fluid pathway of the catheter assembly 10 and/orthe vasculature of the patient.

In some embodiments, the septum 18 may be a low-drag septum designed toreduce friction on the instrument passing through the septum 18, whichmay aid in threading the instrument through the septum 18. In someembodiments, the septum 18 may be configured to withstand high pressureswithin the catheter assembly 10. In some embodiments, the septum housing16 and/or the septum 18 may be secured within the catheter adapter 14 inany number of ways. In some embodiments, the septum housing 16 mayinclude one or more protrusions 34. In some embodiments, the one or moreprotrusions 34 may include a lip. In some embodiments, the septumhousing 16 may be secured to an inner wall of the catheter adapter 14 byone or more of the following: an interference fit between the one ormore protrusions 34 and the inner wall, a snap fit between the one ormore protrusions 34 and the inner wall, bonding between the one or moreprotrusions 34 and the inner wall, and threading securing the one ormore protrusions 34 to the inner wall. In some embodiments, the innerwall may include a groove or opening.

In some embodiments, the septum housing 16 may be resilient, and inresponse to the one or more protrusions 34 aligning with the groove oropening, the septum housing 16 may resiliently move outward to retainthe one or more protrusions 34 within the groove or opening in the snapfit. In further detail, in some embodiments, in response to the septumhousing 16 being inserted into the proximal end of the catheter adapter14, the one or more protrusions 34 may be biased inwardly and/or inresponse to the one or more protrusions being further inserted into theproximal end and aligning with the groove or opening, the one or moreprotrusions 34 may move resiliently outward such that the one or moreprotrusions 34 are retained in the groove or opening.

In some embodiments, the bonding between the septum housing 16 and theinner wall and/or between the septum 18 and the inner wall may bedisposed at various locations on the inner wall. In some embodiments,one or more of the following: adhesive bonding, chemical bonding,ultrasonic welding, and laser welding, may be disposed on all or somesurfaces of the inner wall and/or the septum 18 that are in contact.Additionally or alternatively, one or more of the following: adhesivebonding, chemical bonding, ultrasonic welding, and laser welding, may bedisposed on all or some surfaces of the inner wall and/or the septumhousing 16 that are in contact.

In some embodiments, the septum 18 and/or the septum housing 16 may beretained within the catheter adapter 14 without requiring a mechanicalor interference interface with the septum housing 16. For example, theproximal end of the catheter adapter 14 may abut and extend over aportion of a surface area of a proximal face of the septum 18 and/or theseptum housing 16, thereby retaining the septum 18 and/or the septumhousing 16 within the catheter adapter 14. Thus, the catheter adapter 14may prevent the septum 18 and/or septum housing 16 from movingproximally within the catheter adapter 14 due to a wall at the proximalend of the catheter adapter 14 that abuts and thereby partially blocksthe proximal end of the catheter adapter 14.

Referring now to FIGS. 2A-2B, in some embodiments, the septum 18 mayinclude one or more guiding features that may facilitate guidance of theinstrument distally through the septum 18. As an example, in someembodiments, the septum 18 may include an proximal surface that istapered inwardly in a distal direction such that the proximal surface ofthe septum 18 is configured to guide the instrument distally through theseptum 18. In some embodiments, the proximal surface of the septum 18may be funnel-shaped or conical-shaped. In some embodiments, the septum18 may include a cavity 36. In some embodiments, a distal end of thecavity 36 may include the proximal surface of the septum 18. In someembodiments, a slit 40 of the septum 18 may be disposed at or near acenter of the proximal surface. In some embodiments, the distal end ofthe cavity 36 may include an annular protrusion 38, which may form theproximal surface of the septum 18. In some embodiments, the slit 40 maybe disposed at or near a center of the annular protrusion 38. In someembodiments, the one or more guiding features of the septum 18 mayinclude ribs, protrusions, grooves, or other guiding features that mayfacilitate direction of the instrument. In some embodiments, theproximal surface of the septum 18 may include the one or more guidingfeatures. In some embodiments, guiding the instrument may includecontacting the one or more guiding features.

In some embodiments, the one or more guiding features of the septum 18may be disposed at a proximal end of the septum 18. For example, theproximal surface of the septum 18 may be disposed at a proximal end ofthe septum 18. FIG. 2B illustrates the proximal surface disposed at theproximal end of the septum and the proximal surface as a funnel-shape41, for example.

Referring now to FIGS. 2C-2D, in some embodiments, the septum housing 16may include one or more guiding features that may facilitate guidance ofthe instrument distally through the septum 18 and/or the septum housing16. As an example, in some embodiments, the septum housing 16 mayinclude a proximal surface 39 that is tapered inwardly in the distaldirection such that the proximal surface 39 is configured to guide theinstrument distally through the septum 18. In some embodiments, theproximal surface 39 may be funnel-shaped or conical-shaped. In someembodiments, the septum housing 16 may include a distal end and aproximal end. In some embodiments, the septum 18 may be at leastpartially disposed within the distal end of the septum housing 16. Insome embodiments, the proximal end of the septum housing 16 may includethe proximal surface 39. In some embodiments, the septum housing 16 mayinclude a canister, as illustrated, for example, in FIG. 2D.

In some embodiments, the one or more guiding features of the septumhousing 16 may include ribs, protrusions, grooves, or other guidingfeatures that may facilitate direction of the instrument. In someembodiments, the proximal surface of the septum housing 16 may includethe guiding features. The proximal surface of the septum 18 illustratedin FIG. 2C illustrates the funnel-shape 41, as an example proximalsurface. In some embodiments, a particular port of the catheter adapter14 may include the one or more guiding features of the septum housing 16and/or the septum housing 16 may be integrally formed with theparticular port of the catheter adapter 14.

Referring now to FIGS. 3A-3B, in some embodiments, the catheter systemmay include an introducer 42, which may be configured to introduce theinstrument into the catheter assembly 10. In some embodiments, theinstrument may include another catheter 46, as illustrated, for example,in FIGS. 3A-3B. However, the catheter 46 may be replaced with the probe30, an example of which is illustrated in FIGS. 2A-2C. In someembodiments, the instrument may function as both the probe 30 and theother catheter 46, including elements of both the probe 30 and the othercatheter 46.

In some embodiments, the introducer 42 may include an introducer element44, which may be coupled with the proximal end of the catheter adapter14. In some embodiments, the introducer element 44 may include one ormore guiding features that may facilitate guidance of the instrumentdistally through the septum. As an example, in some embodiments, aproximal end of the introducer element 44 may include an opening 48 atleast partially formed by a proximal and/or inner surface 57, which maybe tapered inwardly in the distal direction such that the inner surface57 is configured to guide the instrument distally through the introducerelement 44 and through the slit 40 of the septum 18. In someembodiments, the inner surface 57 may be conical-shaped orfunnel-shaped, as illustrated, for example, in FIG. 3A. In someembodiments, the inner surface 57 may include one or more ribs,protrusions, grooves, or other guiding features that may facilitatedirection of the instrument.

In some embodiments, the introducer element 44 may include one or morecoupling mechanisms that may facilitate coupling between the proximalend of the catheter adapter 14 and the introducer element 44, which mayprevent fluid leakage and/or contamination of the fluid pathway when theinstrument is inserted within the catheter assembly 14. In furtherdetail, in some embodiments, the introducer element 44 may be coupledwith the proximal end of the catheter adapter 14 in any number of ways,such as, for example, snap-fit, threads, press-fit, interference-fit, oranother suitable means. In some embodiments, a particular couplingmechanism of the introducer element 44 may be coupled to a particularport of the catheter adapter. As illustrated in FIGS. 3A-3B, in someembodiments, one or more protrusions may snap into one or more recessesof the catheter adapter 14.

In some embodiments, the catheter adapter 14 and/or the introducerelement 44 may be monolithically formed as a single piece. In someembodiments, the instrument may be coupled with the introducer element44. In other embodiments, the instrument may not be coupled with theintroducer element 44.

In some embodiments, the introducer 42 may include a sheath or sleeve50, which may be coupled to the introducer element 44. In someembodiments, the sleeve 50 may surround the instrument. In these andother embodiments, the sleeve 50 may shield the instrument fromcontaminants and/or isolate any blood or other fluids that may remain onthe instrument after accessing the fluid pathway of the catheterassembly 10. In these and other embodiments, the sleeve 50 may protectthe instrument from the external environment surrounding the introducer42.

In some embodiments, the instrument may be at least partially disposedwithin the sleeve 50. In some embodiments, the sleeve 50 may constructedof a flexible and/or compliant material. In some embodiments, the sleeve50 may be axially-collapsible or axially-compressible. In furtherdetail, in some embodiments, the instrument may be advanced to aposition beyond a distal end of the sleeve 50 when the sleeve iscollapsed or compressed in the distal direction. In some embodiments,the introducer 42 may include a handle or grip 52, which may be coupledto a proximal end of the sleeve 50. In some embodiments, the clinicianmay move the grip 52 distally to collapse or compress the sleeve 50 inthe distal direction and advance the instrument to the position beyondthe distal end of the sleeve 50.

In some embodiments, various types of sleeves 50 may be used. In someembodiments, the introducer 42 may include a housing (not illustrated),which may be coupled with the introducer element 44. In someembodiments, the housing may include one or more components, such as,for example, concentric barrels. In some embodiments, at least a portionof the housing may be axially-collapsible or axially-compressible. Forexample, a first concentric barrel may be advanced into a secondconcentric barrel.

In some embodiments, the sleeve 50 may be at least partially disposedwithin the housing, which may be rigid or semi-rigid. An example housingis described in U.S. Provisional Patent Application. No. 62/534,552,filed Jul. 19, 2017, entitled “Extension Housing a Probe or IntravenousCatheter,” which is hereby incorporated by reference in its entirety. Insome embodiments, the housing may include a slot. In some embodiments, atab or an adapter may be coupled with the proximal end of the instrumentor near the proximal end of the instrument. In some embodiments, the tabor the adapter may be configured to move along the slot from a proximalposition to a distal position. In some embodiments, in response tomovement of the adapter from the proximal position to the distalposition, the instrument may be advanced beyond the distal end of thesleeve 50 and/or the housing. In some embodiments, the adapter mayinclude a cavity configured to receive a syringe or blood collectiontube and/or a cannula configured to puncture a septum of the syringeand/or the blood collection tube. An example slot and example adapter isdescribed in U.S. Provisional Patent Application. No. 62/534,552, filedJul. 19, 2017, entitled “Extension Housing a Probe or IntravenousCatheter.”

As mentioned, in some embodiments, at least a portion of the housing maybe axially-collapsible or axially-compressible. For example, the housingmay include one or more collapsing and/or telescoping barrels.Additionally or alternatively, the housing may include the slot. In someembodiments, a first concentric barrel may be advanced into a secondconcentric barrel. In some embodiments, at least a portion of the firstconcentric barrel and/or the second concentric barrel may becollapsible.

In some embodiments, the introducer 42 may not include the sleeve 50and/or the grip 52. In these and other embodiments, the introducerelement 44 may have an extended length such that a portion of theintroducer element 44 protrudes from underneath a dressing used to coveran insertion site of the catheter 12, facilitating easy access to theseptum 18 and/or supporting the instrument.

In some embodiments, the introducer element 44, the grip 52, or anotherportion of the introducer 42 may be connected to a luer fitting, BectonDickinson LUER-LOK™ Access Device, or another device for bloodcollection and/or monitoring. In some embodiments, a fluid pathway ofthe introducer 42 may extend through the grip 52. In some embodiments,the introducer element 44, the grip 52, or another portion of theintroducer 42 may be connected to a monitoring interface and/ormonitoring equipment.

Referring now to FIG. 3C, in some embodiments, the introducer element 44may include a coupling mechanism. In some embodiments, a proximal end ofthe introducer element 44 may include the coupling mechanism. In someembodiments, a distal end of the introducer element may include a tube54. In some embodiments, the coupling mechanism may be disposed proximalto the tube 54. In some embodiments, in response to the introducer 42being coupled to the catheter adapter 14 via the coupling mechanism ofthe introducer element 44, the tube 54 may be disposed within the cavity36 and/or proximate a proximal face of the septum 18. In these and otherembodiments, the tube 54 may not penetrate the septum 18. In these andother embodiments, the tube 54 may contact the proximal face of theseptum 18 proximate the slit 40. In some embodiments, the proximal facemay be disposed within the cavity 36, although in some embodiments, theseptum 18 may not include the cavity 36 and/or first and secondproximally-extending arms forming the cavity 36. In some embodiments, awidth of the tube 54 may be approximately equal to a width of the cavity36. In some embodiments, a distal end of the tube 54 may be blunt, whichmay prevent harm to the septum 18. In some embodiments, the tube 54 mayextend from a base 56 portion of the introducer element 44. FIG. 3Cillustrates the probe 30, which may be replaced with the other catheter46, as previously mentioned.

Referring now to FIG. 3D, in some embodiments, the introducer element 44may include a fluid seal, which may prevent fluid from entering a distalopening of the tube 54. For example, the introducer element 44 mayinclude a cover 58, which may be configured to be penetrated by theinstrument and provide a seal between the septum 18 and the introducerelement 44. In some embodiments, the cover 58 disposed over top or atleast partially covering the tube 54. In some embodiments, the cover 58may cover the distal opening of the tube 54. In some embodiments, thecover 58 may be elastomeric and compliant. In some embodiments, thecover 58 may include a slit 60, which may facilitate penetration of thecover 58 by the instrument. In some embodiments, the cover 58 mayinclude one or more antimicrobial agents. In some embodiments, the cover58 may facilitate a fluid seal against the proximal face of the septum18.

In some embodiments, the introducer 42 may include at least one valve59, which may provide a seal that is penetrated by the instrument. Insome embodiments, the valve 59 may include a slit. The valve 59 of theintroducer 42 may be disposed at any number of locations to preventfluid from the catheter assembly 10 from entering all or a portion ofthe introducer 42 and/or exiting the proximal end of the introducer. Anexample valve 59 is illustrated in FIG. 3D. In some embodiments, theintroducer 42 may include the valve 59 and/or the cover 58. In someembodiments, when the introducer 42 does not penetrate the septum 18,such as, for example, in FIG. 3C, the introducer 42 may not include thevalve 59 and/or the cover 58.

In some embodiments, any of the components of the catheter system,including any component of the introducer 42 and/or any component of thecatheter assembly 10, for example, may include one or more antimicrobialagents, such as for example, an antimicrobial coating antimicrobiallubricant, etc. In some embodiments, the antimicrobial agents may reducea risk of contamination of a fluid pathway of the catheter system.

Referring now to FIGS. 4A-4B, in some embodiments, in response to theintroducer 42 being coupled to the catheter adapter 14 via the couplingmechanism of the introducer element 44, the tube 54 may penetrate theseptum 18. In these and other embodiments, fluid within the cavity 36 ofthe septum 18 may be reduced and/or a compressive axial load on theinstrument may be decreased compared to when the instrument itself opensthe septum 18. In some embodiments, a distal end of the tube 54 may beblunt, which may prevent harm to the septum 18. In some embodiments, theintroducer 42 of FIGS. 4A-4B may include one or more of the sleeve 50,the grip 52, and one or more other components discussed with respect toFIGS. 1-3. FIG. 4 illustrates the catheter 46 prior to insertion withinthe introducer 44, according to some embodiments.

Another example valve 59 is illustrated in FIG. 4B. In some embodiments,the valve 59 may be disposed within a needleless connector. In someembodiments, the needleless connector may form a proximal end of theintroducer element 44. In some embodiments, the valve 59 may be disposedwithin the catheter adapter 14 distal to the septum 18. In theseembodiments, the tube 54 may penetrate the septum 18 but not the valve59, which may be penetrated by the instrument. In some embodiments, thevalve 59 may provide less resistance to the instrument than the septum18.

Referring now to FIG. 5, as explained previously, in some embodiments,the introducer element 44 may be coupled with the proximal end of thecatheter adapter 14 via any number of coupling mechanisms. For example,the introducer element 44 may be coupled with the proximal end of thecatheter adapter via a snap-fit, threads, a press-fit, aninterference-fit, etc. In some embodiments, the introducer 44 mayinclude a connector 62, which may include the one or more couplingmechanisms, such as, for example, threads, as illustrated in FIG. 5. Insome embodiments, the connector 62 may be coupled to the proximal end ofcatheter adapter 14 via the one or more coupling mechanisms. In someembodiments, the connector 62 may be removable from the introducerelement 44 and/or the catheter adapter 14. In other embodiments, theconnector 62 may be non-removable from or permanently coupled to theintroducer element 44 and/or the catheter adapter 14. FIG. 5 illustratesthe introducer element 44 coupled with the sleeve 50, according to someembodiments.

The present invention may be embodied in other specific forms withoutdeparting from its structures, methods, or other essentialcharacteristics as broadly described herein and claimed hereinafter. Thedescribed embodiments are to be considered in all respects only asillustrative, and not restrictive. The scope of the invention is,therefore, indicated by the appended claims, rather than by theforegoing description. All changes that come within the meaning andrange of equivalency of the claims are to be embraced within theirscope.

1. A catheter assembly, comprising: a catheter adapter, comprising adistal end, a proximal end, and lumen extending therebetween; and aseptum disposed within the lumen, wherein the septum comprises aproximal surface that is tapered inwardly in a distal direction suchthat the proximal surface is configured to guide a probe or catheterdistally through the septum.
 2. The catheter assembly of claim 1,wherein the septum comprises a cavity, wherein a distal end of thecavity comprises an annular protrusion, wherein annular protrusion formsthe proximal surface.
 3. The catheter assembly of claim 2, wherein theseptum further comprises a slit disposed in a center of the annularprotrusion.
 4. The catheter assembly of claim 1, further comprisingextension tubing, wherein the proximal end of the catheter adaptercomprises a first port and a second port, wherein the lumen comprises afirst lumen, a second lumen, and a common lumen, wherein the first portforms the first lumen, the second port forms the second lumen, whereinthe first lumen and the second lumen join at the common lumen, whereinthe first lumen is generally aligned with the common lumen, wherein theseptum is disposed in the first lumen to prevent fluid from exiting thecatheter adapter through the first port, wherein the second port iscoupled to the extension tubing.
 5. The catheter assembly of claim 1,further comprising a septum housing, wherein the septum is at leastpartially disposed within the septum housing, wherein the septum housingcomprises a proximal surface that is tapered inwardly in the distaldirection such that the proximal surface is configured to guide theprobe or the catheter distally through the septum.
 6. The catheterassembly of claim 5, wherein the septum housing comprises a distal endand a proximal end, wherein the septum is disposed at least partiallywithin the distal end of the septum housing, wherein the proximal end ofthe septum housing comprises the proximal surface.